Recently in Defective Products and Devices Category

The Toyota Motor Corp. and U.S. subsidiaries have agreed to settle investigations by 29 attorneys general and will pay 29 million dollars to participating states. The settlement closes the claims with these states that the company misled consumers about the safety of its vehicles.

Toyota has been paying out significant reparations for many safety and communications issues associated with various defects. For example, the company already paid a large sum totaling $48.8 million to the National Highway Traffic Safety Administration for its failure to let regulators know about defects that became the subject of recalls.

The company has also recently agreed to pay about $1.4 billion to end national class action claims that its vehicles suddenly and unintentionally accelerated, which devalued the owner's vehicles. The company had been sued by hundreds of owners since about 2009, when the car maker began receiving complaints about the sudden acceleration issue. Some individual cases involving injury and death due to the defect may still be litigated. The company is said to be trying to settle some of the larger of these cases before they get to juries.

The state investigations resulted from the claims of sudden acceleration. The company had insisted that its vehicles were safe, despite recurring issues with the acceleration systems in several models. Toyota has agreed to correct communications issues between Japan and the United States with regard to safety problems. It must also advise buyers about defects in previously-owned vehicles and repairs made on those cars.

The federal government has sued the manufacturer of the Nap Nanny, sold in stores nationwide including San Francisco, because the products' maker has failed to voluntarily recall it. As San Francisco child injury lawyers, with a long history of expertise in infant safety recalls, we applaud the efforts of the Consumer Product Safety Commission.

The problem with the product is that "at least five infant deaths and more than 70 complaints" of infants falling out have been provided to the federal government. They say that the maker of this product was not providing sufficient warnings to consumers about the dangers and risks associated with it.

The Nap Nanny has been sold for several years and includes a foam pad with a cover made of fabric. The baby is supposed to be strapped into a three-point harness. The product has been sold in several versions, but essentially it is a baby recliner designed for sleep, rest, and play.

The original Nap Nappy was recalled in July of 2010 after one infant died and 22 others were found hanging out or falling over the edge. The CPSC says that the manufacturer has not warned consumers of the risks of using it, even after these incidents occurred.

According to the CPSC, the various generations of the product contain "defects in the design, warnings, and instructions that pose a substantial risk of death and injury to infants." The government has asked that the manufacturer cease selling the products and let the public know that it is not only defective, but that they are entitled to a full refund for it.

The CPSC noted that after its staff had discussed this course of action, the company refused to recall the product voluntarily in a way that "would address the hazard posed by consumer use of the product in a crib or without the harness straps being securely fastened." Instead, the manufacturer says that they "stand behind the safety of the product when used as instructed." They say that parents whose children have been injured or have died did not use the product correctly and that the product is not dangerous when used properly.

We urge parents to review their use of this and other child and infant products. If you purchased one of these products, return it to the store where it was purchased and let them know you are aware that the federal government says it is unsafe.

Over this past year, we have brought our readers stories and information about serious potential for injury related to medical devices, drugs and other products. We have told you about infant and child safety and recalls related to products that have, or might, cause injury and harm to kids. We have informed you about the victims of defective medical devices, such as defective DePuy Hip Implants, and pharmaceuticals.

We successfully litigated several very important wage and hour cases, including those involving Terminix and Marcus & Millichap. In these actions, we were able to secure employees of these companies the wages they were due and had not been paid.

In the Terminix matter, we presented as co-counsel, a landmark case that involved the company's failure to provide rest breaks and required inspectors to work more than the number of hours per day allowed under California law. The inspectors also worked nights and weekends without additional compensation, which was a failure to pay overtime wages. The jury returned a verdict that protected workers' rights.

We settled a major case involving a man who suffered a Mild Traumatic Brain Injury that was caused by a rear-end collision. The significance of this matter has broad implications for those who have been seriously injured, but whose injuries in the past have been ignored because, for example, they do not show up on an MRI. We helped determine and prove that this man had suffered major memory loss, impaired cognition and other debilitating problems, due to a rear-end collision. This injury is only now becoming better understood by experts in brain injury.

We will continue to dedicate our law practice the protection of consumers and the public. If you have any questions about what we do or how we might help you, please contact our law firm to speak with one of our lawyers. Our consultation on any injury or consumer matter is free of charge.

The lawyers of Hersh & Hersh wish all our readers a very happy and healthy 2012.

Earlier this month, we advised our readers that the FDA had issued a safety warning regarding the use of transvaginal surgical mesh in various surgeries for women suffering from conditions such as pelvic organ prolapse. The FDA's action was the result of thousands of women reporting serious complications with this implantable device.

In a recent article in the Chicago Tribune, that was also published by the LA Times, examples of the complications women have suffered have been reported in great detail. As personal injury lawyers representing women who have suffered from these complications, we are painfully aware of them. There are other ways for surgeons to correct medical conditions such as pelvic prolapse and patients must be very cautious in allowing a surgeon to insert surgical mesh transvaginally.

The recent press on these procedures appears to target the lack of training of some surgeons performing these procedures and using this device. And as is pointed out in the Chicago Tribune piece "the FDA hasn't required companies selling mesh products to prove they're safe or effective when used in the pelvis, even though the potential harm can be substantial."

We are well-aware of the serious medical consequences women have suffered when the mesh is used for pelvic prolapse and related surgeries. And once implanted, it is often difficult if not impossible to remove the mesh due to the development of scar tissue surrounding the device.

The renowned Mayo Clinic in Rochester, Minnesota and some other major clinics, will simply not perform these procedures using surgical mesh. They prefer to use other very viable ways to correct these issues through the abdomen.

But as reported in the Chicago Tribune, some doctors believe there are patients for whom this is the best alternative where anesthesia use can be a risk factor or for women with recurrence of prolapse. They seem to point to the surgeon's skill and training as the issue, rather than an inherent problem with the use of mesh in this context.

However, the FDA has had thousands of reports of complications. As injury lawyers who have helped women suffering from some of the excruciating and life-changing results of the use of transvaginal surgical mesh, we urge patients to talk with their doctors about the risks of the use of mesh.

While mesh may be a possible corrective device in other types of surgeries, such as hernia repairs, using this transvaginally may not be a risk that should be taken when the complications can be worse than the original condition. Clinical outcomes have not been shown to be better using surgical mesh -- this is something that all patients looking for surgical correction should consider.

As noted in the Chicago Tribune piece, the FDA is looking at various "regulatory options related to mesh, including reassigning products used in vaginal prolapse surgeries to Class III, the most tightly regulated type of device. Should that occur, companies would have to provide much more data about the products' effectiveness both before and after they come out on the market."

An FDA public hearing in September is expected to bring out many women who have suffered from the use of this device. The agency will be considering its fast track approval of the use of mesh for this purpose and could reclassify it, making it far more stringent for companies advocating its use in this context.

We urge women to contact our law office to discuss complications from the use of mesh in their surgeries. We will consult with you at no charge.

As California personal injury lawyers, we deal with a wide variety of defective products and devices that have caused injury or death. Recently, we shared with our readers the FDA's safety warning concerning surgical vaginal mesh, which is implanted in women to correct various medical problems, but has been shown to have serious adverse consequences in many patients. And we are involved in the recent recall of DePuy's defective hip implants, representing clients who have been implanted with these devices.

Another major area of our injury law practice relates to dangerous or defective products that have harmed or killed children. Our law firm was at the forefront of the largest crib recall in the history of the country. We are always interested in safety improvements to all products, including those intended for children.

Earlier this month, the U.S. Consumer Product Safety Commission (CPSC) voted to approve a new safety rule for children's outerwear. The final rule covers certain outwear and other clothing with drawstrings around the neck or waist. These have been found to have a serious risk of entanglement in playground equipment and car doors.

Twenty-six children have reportedly died after a drawstring became tangled on a playground or in a vehicle door. These incidents include dragging hazards as well as strangulation hazards.

The agency issued guidelines for a voluntary industry standard in the late 1990's, and fatal accidents have declined. But unfortunately, there are still many non-compliant products on the market and the agency has recalled over 100 of these in the past four or five years.

In a related matter, the CPSC has settled with Macy's Inc., of Cincinnati, Ohio, which will pay a civil penalty of $750,000 for selling non-compliant drawstring clothing for children for a period of four years. Although Macy's denies knowingly selling recalled products or failing to immediately report the sale of non-compliant products, they apparently are willing to pay a price to close the matter with the agency. The settlement includes sweatshirts, sweaters and jackets sold at either Macy's stores, or stores owned by the company including Bloomingdales and Robinsons-May.

Retailers and distributors have specific reporting obligations under federal law to report information that supports "the conclusion that a product contains a defect which could create a substantial product hazard, creates an unreasonable risk of serious injury or death, or fails to comply with any consumer product safety rule or any other rule, regulation, standard or ban enforced by CPSC."

This particular hazardous group of products is still of concern to the CPSC. They want to know about incidents or injuries involving these products on an ongoing basis.

The injury lawyers at San Francisco, California's Hersh & Hersh, have represented victims harmed by defective medical devices and other products for over four decades. Please contact our law office for a free consultation regarding your situation with one of our trial attorneys.

Two types of Depuy ASR hips were recalled by the manufacturer. Between 2005 and 2009, nearly 95,000 patients were implanted with either the ASR XL Acetabular System or the ASR Hip Resurfacing System. The sheer numbers involved in hip replacement surgeries make a recall of these devices particularly disturbing.

These hip implants have been shown to deposit dangerous levels of metal debris in some patients' bodies and blood streams. This will result in high levels of particular metals in patients that include chromium and cobalt, among others. Friction occurs with these hip replacements, due to their metal-on-metal design and that is how the metals end up becoming debris in the patient's body.

The result of the defects is that many patients who were implanted with these devices will need to undergo another surgery to remove them. In these revision surgeries, the defective devices will be removed and will be replaced with another hip implant.

Sadly, many of the implanted patients are elderly and will have a difficult time with a second major surgery that will be required. Regardless of age, this is a major surgery and having to have a second hip surgery due to a defect in the implant, is a terrible outcome for those patients that will have to undergo this ordeal. In addition to the issues with metals in the blood, patients have experienced pain, hip popping, difficulty walking and many other symptoms.

Given that the manufacturer will not compensate patients at the level needed for long-term care, surgeries, lost wages and/or emotional distress, it is very important that patients who have been implanted with the DePuy hip replacement implant contact experienced defective medical device lawyers.

Our affiliated consumer law firm, San Francisco's Hersh & Hersh, has been at the center of the cases involving infant deaths due to defective and unsafe cribs. Our work was instrumental in securing major recalls concerning infant safety and we were involved in the largest recall of cribs and bassinettes in American history.

Many Americans have been asking the CSPC questions regarding the new rules. According to the federal government, most questions have concerned the drip side, but the new standard impacts more than the drop side and includes: the crib's mattress support, slats, and hardware.

The new standards require all of these to be more durable. In addition, crib manufacturers must test their cribs and have a higher burden to prove to the government that they have complied through rigorous testing. The new standards go into effect on June 28, 2011.

Childcare centers and public accommodations must comply by December 28, 2012.
It is very important for consumers to know that not only does the new standard involve new cribs it also involves resale of cribs. Both full-size and non full-size cribs are covered.

Preston Maxwell died at age seven weeks. His dad put him to bed one night earlier this year and by morning the baby was found dead in his crib. The baby was found with his nose "pressed between the mattress and crib bumper pad" and his autopsy report concluded that he had suffocated. In other words, the baby's face ended up wedged between the mattress and crib bumper pad.

According to the Tribune article, the "U.S. Consumer Product Safety Commission said it will re-examine the safety of crib bumpers." This will include reopening files on infant deaths to evaluate the "safety of bumper pads on store shelves and rethinking how investigators examine deaths where bumper pads are present."

It is not yet known how many infant deaths have been caused by crib bumpers, but since the CPSC is now taking another look at this product, there might well be many more deaths that will in the end be attributed to something that has been present in baby nurseries for years.

One pediatrician studied the safety of bumper pads and three years ago issued a report that concluded 27 infant deaths were caused by these products over two decades. He used CPSC data to determine this.

In some cases, the deaths have been erroneously attributed to SIDS, when in fact other circumstances in these baby's cribs were overlooked. Due to the pediatrician's report, the American Academy of Pediatrics suggested that parents avoid the use of crib bumpers.

Another product in many infant cribs are sleep positioners. These are supposed to keep infants from rolling onto their stomach which is suspected as a cause of SIDS. In Preston's case, he was placed in a crib positioner, but "rolled out of his positioner and landed with his face between the bumper pad and mattress," states the Tribute article.

This past fall, the FDA urged parents to stop using these positioners and issued a warning concerning them. Additionally, the FDA sought the halting of manufacturing and selling of this product.

The national consumer lawyers of California's Hersh & Hersh would like parents to ensure their infants are safe. If you would like more information on the dangers of crib bumper and/or baby positioners, please contact our law firm to speak with one of our lawyers.

Some of the key improvements to the ratings system include such specifics as side pole crash testing and crash prevention-technologies.

Safety has no gender and another area of change is that, yes, for the very first time the new system will use female crash test dummies to simulate crashes. Prior to this, male crash test dummies were used exclusively.

Secretary LaHood said that the new system is "raising the bar on safety." He continued by saying that the "new tests, better crash data, and higher standards" will toughen-up the safety ratings and provide more meaningful information for consumers.

The new ratings cover three big areas of concern: frontal crash, side crash, and rollover resistance. Several specifics will be helpful for consumers in determining safety, including electronic stability control, lane departure warning, and forward collision warning systems. There will also be an Overall Vehicle Score for every car tested.

The San Francisco law firm of Hersh & Hersh has a long history of improving the health and safety of the consuming public. We are pleased that the new safety ratings criteria have been put in place to help consumers identify potentially safer vehicles. If you have any questions about our representation of victims and their families in personal injury and auto accident cases, contact our California office to speak directly with one of our attorneys.

Yesterday Fisher-Price recalled an unprecedented 10 million products that it sold in the United States. The United States Consumer Safety Commission has posted a list of products with pictures for consumers to carefully check their children's toy collections and contact Fisher-Price for repair kits.

Please check the CPSC website link above and then check your children's toys. Above all, stop using these toys until you have determined they have been repaired and the dangers corrected.

TRIKES
Among the recalled toys are 14 toddler tricycles seen on patios and sidewalks around the country. These can cause serious injury due to a plastic ignition key that is positioned in front of the child seat. Injury has been caused when children sit or fall against this "pretend" key. These tricycles are Trike and Tough Trike models.

INFANT ACTIVITY CENTERS
Another major area of the recall is an infant activity center that has inflatable balls included. The problem with these activity centers is the inflatable ball valve. The valve has come off and has been found in 14 infant's mouths, with three reports of infants starting to choke on these valves. According to the CPSC, 46 valves have been reported to have come off.

HIGH CHAIRS
Nearly 950,000 high chairs have been recalled due to a danger involved with children falling against the back legs of the chair and being injured on pegs located there. Seven injuries have been reported thus far.

LITTLE PEOPLE VEHICLES
Another area of the recall is a toy called Little People vehicles. The wheels have detached from this toy. The Fisher-Price Little People Wheelies Stand 'n Play Rampway poses a choking hazard to young children.

TAKE ACTION
The California Injury Attorney Blog and the lawyers at Hersh & Hersh have been involved in protecting the public from dangerous products, including the largest crib recall in the history of the United States. We have represented the families of children who have been injured or have died while using a dangerous product.

If your child has been injured by one of these recalled products contact Fisher-Price and the CPSC. The agency credits concerned parents, who reported injuries and problems with these toys, with the information needed to help with this recall.

And remember, if you have purchased one of these toys in a store, garage sale or have been given a "hand-me-down" from a family member or friend, carefully check these recalled products to ensure your child is not using a recalled product or toy.

The California Injury Attorney Blog tracks national drug and product recalls. Most recently, the nation has been under a massive recall of shell eggs. This is a significant food safety issue and we want our readers to take precautions to avoid illness.

The recent recalls became necessary after hundreds of consumers across the country became ill with Salmonella Enteritidis (SE). This illness can be serious and is a common cause of food poisoning.

Millions of shell eggs have now been recalled from store shelves. The FDA also has extensive questions and answers on its website to help consumers avoid becoming ill from these eggs.

The recall involves Wright County Egg and Hillandale Farms, Inc. both of which are the subject of ongoing investigations that include environmental sampling at company facilities. The sampling indicates that these facilities are the source of the contaminated shell eggs. More specifically, the bacteria may have originated at the feed mill for these facilities, which is located several miles away.

There are many brand names involved in this recall because the eggs are packaged and distributed by many companies around the country. About 500 million eggs are now involved in the recall. A list of the brands involved can be viewed here.

The FDA says that it is continuing its investigation of the sources of the contamination. That includes assessments of farm conditions, including environmental sampling. Other important areas are being reviewed such as sanitation, security and the like.
Investigators are also looking at whether these facilities share common practices and sources that could lead to such a large contamination.

This is the largest national Salmonella outbreak since records on such outbreaks started in 1970. The largest prior outbreak was in 1994 and involved ice cream.

The FDA continues to issue inspection reports for some of the companies that have been subject to the recall. If you would like to read these reports, click here and here.

Surgical mesh is often used to repair these conditions and is placed transvaginally, sometimes with the use of surgical tools that are considered minimally invasive. There are a number of vaginal mesh manufacturers and many of them have reported complications to the Food and Drug Administration (FDA).

The complications associated with this procedure can be very serious. The complications that have been most often reported include: infection, pain, vaginal epithelium erosion, urinary problems, and the return of the very conditions for which the procedure was performed in the first place. Additional complications include perforations that occur during the procedure of the bladder, bowels and blood vessels.

All of the complications associated with the use of transvaginal surgical mesh can bring pain and discomfort to patients, as well as a major reduction in quality of life. Sometimes, the treatment for these problems includes the removal of the mesh. Other treatments include those for infection and other conditions caused by the procedure or subsequent problems arising after the procedure.

If you, or a loved one, has had a surgical mesh procedure and has experienced pain, discomfort or the POP or SUI has not improved, you may need additional treatment.

Earlier this month Pottery Barn Kids issued a voluntary recall for repair of its drop-side cribs. There are about 82,000 of these in the marketplace.

The hazard involves entrapment, which can lead to suffocation and the possibility of a fall. The cribs' drop-sides can detach when hardware breaks. Pottery Barn Kids wants consumers to stop using these cribs and to contact the company to receive a free kit intended to correct the problem.

The Pottery Barn Kids crib recall underscores the larger issues with crib safety, which are currently being addressed by the United States Consumer Product Safety Commission (CPSC). The CPSC has recently proposed new testing rules for full-size and smaller cribs. The purpose of the new standards is to deal with the serious and sometimes tragic consequences of defective and poorly designed infant cribs.

The California Injury Attorney Blog has posted on the dangers of defective cribs and bassinettes. Moreover, Hersh & Hersh has been involved with some of the most important crib and bassinette recalls in United States history. We have represented families that have suffered tragic losses due to these defective products.

Over the past several years, we have seen defects that include dangers due to defective design and hardware, detachment of side rails and other defects that have resulted in entrapment and suffocation deaths or falls.

The mandated improvements are based on The Consumer Product Safety Improvement Act of 2008 (CPSIA). This Act required mandatory safety standards for infant and toddler products.

The recent rules are the subject of a notice of proposed rulemaking. The specific details of the proposed modifications can be found here. Briefly, summarized, the essential modifications require specific crib testing such as mattress support, side impact and stress tests in which screws would not be tightened to replicate long term use.
According to the CPSC, its staff expects to finalize the proposed mandatory crib standards in 2010.

Web Resources

The public can report a dangerous product or a product-related injury to the CPSC Hotline at (800) 638-2772. Visit CPSC's web site at www.cpsc.gov.

Reuters is reporting that an email from an FDA reviewer and known whistleblower appears to confirm findings that the diabetes drug Avandia carries a risk of serious cardiovascular problems. The findings have not yet been published, but as the California Injury Attorney Blog noted recently, the FDA is about to host its public meeting scheduled in July to report on the safety risks associated with Avandia.

The latest study apparently shows increased risks in the following percentages: risk of stroke 27%; risk of heart attack 25%; and, risk of death 17%. The research was based on data from about 230,000 patients, mainly over 65 years of age.

These findings, as well as the FDA's review of another major study, will be presented at the July advisory panel meeting. Avandia sales have dropped since a 2007 Cleveland Clinic study. It is widely thought the drug may be taken off the market after the July meeting.

The California Injury Attorney Blog posted recently on the recall of Children's Tylenol. The fact is, as consumer protection attorneys, we have been at the center of infant safety for many years and our lawyers have represented children and families who have been hurt by defective drugs and devices.

For example, in recent years we were at the center of the largest national crib recall, representing a family whose infant died due to a defective crib. We also represented those injured by defective bassinettes and supported the subsequent national basinette recall.

We have represented and supported grieving families and brought them some closure for tragic events. And now, we post on the final chapter of another tragedy involving infants and their families.

The National Law Journal reports that Judge Fitzwater, chief judge of the U.S. District Court for the Northern District of Texas, will issue final approval for a major class action settlement. The case settles the class action involving the death of some 40 babies who died after receiving intravenous doses of E-Ferol, a vitamin E supplement used during the 1980's.

About 90 hospitals administered the supplement to premature infants without approval by the Food and Drug Administration. The vitamin was supposed to help prevent conditions involving visual impairment and blindness. Instead, it caused brain bleeds, as well as liver and kidney failure.

The class included 369 plaintiffs -- other cases involving about 50 infant deaths were settled prior to the class action certification. The class alleged that the now defunct manufacturer and distributor, whose executives were convicted of conspiracy in the late 1980's, had led hospitals to believe the FDA had approved the use of the supplement, when in fact it had not.

This settlement brings closure to litigation involving a tragic loss of life.

San Francisco's Hersh & Hersh represents the victims of defective products and devices and has represented parents whose children have been injured or have died due to these defects. Please contact our office for a free consultation with a lawyer.

We represent our clients with compassion and experience in the most difficult times in their lives. We are here to help.